- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02090400
Switching From Oral Bisphosphonates to Bazedoxifene to Evaluate Effects on Bone Mineral Density in Postmenopausal Women
Multi-centre, Randomized, Open Label Trial to Evaluate the Effects of Switching to Bazedoxifene in Comparison With Switching to Calcium and Vitamin D in Postmenopausal Women Previously Treated With Bisphosphonates
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The primary hypothesis is: "Comparing to control group (Calcium+VitD), Bazedoxifene group (20mg daily+ calcium+VitD) is efficient in reducing BMD in spine at 12 months of treatment. in postmenopausal women switching from daily, weekly or monthly bisphosphonates therapy. It is a non-inferiority study of Bazedoxifene compared to biphosphonates, being each patient its own control from the baseline. It is a superiority study of Bazedoxifene compared to Calcium+VitD.
Taking into account the difference in the percentage change observed in the total BMD of the spine during 12 months in those patients treated with Bazedoxifene+Ca+VitD at least 110 patients should be included, 55 in each arm of treatment.
This simple size is going to allow us to detect the differences in the percentage change observed in the total BMD of the spine during 12 months between the two treatment arms, being the same or over 0.25%, with a significance level of 95%, an 80% power. It is estimated a standard deviation of 0.5%, and a 10% lost follow-up rate.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
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Madrid, Spain, 28009
- Instituto Palacios
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Madrid, Spain, 28001
- Gabinete Médico Velázquez
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Madrid, Spain, 28023
- Instituto de Ginecología EGR
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Ambulatory postmenopausal women 55 years or older at screening
- Have received daily, weekly or monthly oral bisphosphonates at least for 3 years and treatment change is indicated (not responses to bisphosphonates, for bad tolerability or for the potential risk of side effects in a long term treatment with bisphosphonates-indicated by Federal Drug Administration, European Medicines Agency.
- Subjects has stop bisphosphonates therapy no more than one month before screening visit for subjects in daily or weekly bisphosphonates
- Subjects has stop bisphosphonates therapy no more than two months before screening visit for subjects in monthly bisphosphonates
- Screening T-score at the lumbar spine ≤ -2.0 to -4.0 by Dual X ray Absorptiometry (DXA) scan
- At least 2 lumbar vertebrae must be evaluable by DXA
- Al least one hip must be evaluable by DXA (for secondary objectives)
Exclusion Criteria:
- Any disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures
- Current use of medication prescribed for osteoporosis other than oral bisphosphonates
- Subjects who had received intravenous bisphosphonates or fluoride (except for dental treatment)
- Subjects who had received any Selective Estrogens Receptor Modulator (SERM), anabolic steroids, systemic hormone replacement, calcitonin or calcitriol within 3 months.
- Subjects who had received strontium ranelate, parathyroid hormone (PTH) or PTH derivates within 1 year.
- Hyper or hypothyroidism, current hyper or hypoparathyroidism
- History of Venous Thromboembolism Event (VTE)
- Significantly impaired renal function as determined by estimated Glomerular Filtration Rate less 35 mL/min
- Hyper or hypocalcemia
- Vitamin D deficiency (serum 25 (OH) vit D level < 20 ng/mL (< 50nmol/L)
- Any condition that could result in impaired calcium metabolism or metabolic bone disease that could interfere with interpretation findings
Study Plan
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Bazedoxifene & Calcium/Vit D
Bazedoxifene 20mg oral once a day and calcium 500mg and 400 IU vitamin D (OSTINE)
|
20 mg Oral daily for 12 months
Other Names:
Calcium 500 mg / 400 IU Vit D
Other Names:
|
Other: Calcium/Vit D
Calcium 500mg and 400 IU vitamin D (OSTINE )daily.
|
Calcium 500 mg / 400 IU Vit D
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Lumbar Spine Bone Mineral Density (BMD)
Time Frame: 12 months
|
To evaluate the change in Lumbar Spine Bone Mineral Density (BMD)
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Bone Turnover Markers (BTM´s) carboxy-terminal collagen crosslinks (CTX) and 1 procollagen N-terminal (P1NP)
Time Frame: 6 and 12 months from baseline
|
To evaluate the effects of switching to Bazedoxifene 20mg in comparison with switching to calcium 500mg and 400 International Units (IU) vitamin D (OSTINE) daily on BTM's CTX and P1NP
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6 and 12 months from baseline
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BMD at the femoral neck
Time Frame: 6 and 12 months from baseline
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To evaluate the effects of switching to Bazedoxifene 20mg in comparison with switching to calcium 500mg and 400 IU vitamin D (OSTINE) daily on BMD at the femoral neck
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6 and 12 months from baseline
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BMD at total hip
Time Frame: 6 and 12 months from baseline
|
To evaluate the effects of switching to Bazedoxifene 20mg in comparison with switching to calcium 500mg and 400 IU vitamin D (OSTINE) daily on BMD at total hip
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6 and 12 months from baseline
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Mammography
Time Frame: 12 months from baseline
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Changes in Mammography at12 months from baseline in the Breast Imaging Report and Database System (BI-RADS) classification
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12 months from baseline
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Subject reported treatment satisfaction using the Treatment Satisfaction Questionnaire for Medication (TSQM) and gastrointestinal symptoms using the Gastrointestinal Symptoms Rating Scale (GSRS)the Spanish versions
Time Frame: At baseline, months 6 and 12
|
To evaluate the effects of switching to Bazedoxifene 20mg in comparison with switching to calcium 500mg and 400 IU vitamin D (OSTINE)daily on Subject reported treatment satisfaction using the Treatment Satisfaction Questionnaire for Medication (TSQM) and gastrointestinal symptoms using the Gastrointestinal Symptoms Rating Scale (GSRS)the Spanish versions
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At baseline, months 6 and 12
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Santiago Palacios, MD
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Metabolic Diseases
- Musculoskeletal Diseases
- Bone Diseases
- Bone Diseases, Metabolic
- Osteoporosis
- Osteoporosis, Postmenopausal
- Physiological Effects of Drugs
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Hormone Antagonists
- Bone Density Conservation Agents
- Calcium-Regulating Hormones and Agents
- Selective Estrogen Receptor Modulators
- Estrogen Receptor Modulators
- Calcium
- Bazedoxifene
Other Study ID Numbers
- IP-2012-01
- 2012-003131-28 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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